A basic medical sealer requires four basic components to work properly: a solenoid or pneumatic piston, a jaw mechanism, a heating element, and a microprocessor. Referring to FIGS. 1 and 3, the machine 10 of a basic medical sealer includes a solenoid 12 (FIG. 3) and a jaw mechanism 13 comprised of an upper jaw 14 and a lower jaw 16. Solenoid or pneumatic piston 12 engages the jaw mechanism to pull the upper jaw 14 down onto lower jaw 16 in order to apply the necessary pressure to the flexible package or pouch. Solenoid 12 has a pre-defined pressure that is fine-tunable by a control knob 18 on the upper jaw assembly.
As shown in FIG. 3, a heating element 20 flash heats to the required temperature to melt the packaging material. Heating element 20 maintains the temperature for a specific time to create a bond. Pieces of Teflon, Sarcon, and glass cloth are disposed on either side of heating element 20 and prevent the packaging materials from sticking to the upper and lower jaws. The heating element is controlled by a microprocessor 22, shown in FIG. 2, with a thermocouple interface to assure the accuracy of the temperature. Microprocessor 22 also controls the cooling time during which the jaws stay closed before the material can be removed from the machine.
Packages sealed by medical sealers must meet government standards; therefore, the seal integrity of packages must be routinely tested during production. There are different tests for inspecting seal integrity, the most common being peel testing and visual testing. Peel testing is the most common way to determine seal strength utilizing destructive methodology. These test modalities are used when developing the Design of Experiments for the validation processes. The visual process is used most often as an in-process system of seal inspection as it is non-destructive. Peel testing measures the strength of seal in pounds while visual testing analyzes seal integrity for pleating, cracking, bubbling, etc. Basic medical sealers used in the art today do not include a mechanism for thorough inspection of seal integrity of the package being sealed. Currently, when a medical packager seals a pouch using a medical sealer, he or she must occasionally pull a pouch out of production to test the seal. Testing the seal usually involves taking it to a lab where the material is cut into a one-inch strip and pulling the material apart using, for example, an industrial ASTM F-88 seal strength test to determine the integrity of the seal. Alternatively, devices such as those disclosed in U.S. Pat. No. 5,515,159 to Sikes, U.S. Pat. No. 6,097,427 to Dey et al., and U.S. Pat. No. 5,732,529 to Dey et al. are used, wherein the medical packager removes the package from production after it has been sealed and inspects the package with a light and a video camera.